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Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)

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ClinicalTrials.gov Identifier: NCT00725101
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : June 1, 2012
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Fibromyalgia
Intervention Drug: Treatment for Fibromyalgia
Enrollment 1700
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description FM participants starting any new pharmacologic FM agent.
Period Title: Overall Study
Started 1700
Completed 1205
Not Completed 495
Reason Not Completed
Death             3
Lost to Follow-up             353
Protocol Violation             1
Withdrawal by Subject             127
not specified/no reason given             11
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description FM participants starting any new pharmacologic FM agent.
Overall Number of Baseline Participants 1700
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1700 participants
50.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1700 participants
Female
1601
  94.2%
Male
99
   5.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1700 participants
White 1391
Hispanic 209
Other 100
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1700 participants
United States 1539
Puerto Rico 161
Number of Unique Baseline Medications Taken for Fibromyalgia (FM; Newly-Initiated and Continuing)  
Measure Type: Number
Unit of measure:  Unique baseline medications
Number Analyzed 1700 participants
181
Mean Number of Concurrent Baseline Medications Taken for Fibromyalgia (FM)  
Mean (Standard Deviation)
Unit of measure:  Concurrent baseline medications
Number Analyzed 1700 participants
2.6  (1.2)
Brief Pain Inventory-Severity (BPI-S) Average Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1700 participants
5.5  (1.8)
[1]
Measure Description: BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine) for each question assessing worst pain, least pain, and average pain in the past 24 hours, and current pain.
Brief Pain Inventory-Interference (BPI-I) Average Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1700 participants
6.1  (2.2)
[1]
Measure Description: Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Fibromyalgia Impact Questionnaire (FIQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1700 participants
54.4  (13.7)
[1]
Measure Description: FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ has 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0 to 80; Higher score=greater negative impact.
Sheehan Disability Scale (SDS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1700 participants
18.3  (7.6)
[1]
Measure Description: SDS is a self-rated measurement of disability across 3 domains: work/school, social life, and family life/home responsibilities. Participant marks along the line from 0 (not at all) to 10 (extremely disrupted), the number that best represents how much each area is disrupted by fibromyalgia symptoms.
Opioid Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1700 participants
No 1288
Yes 412
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1700 participants
No 1245
Yes 455
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1700 participants
Felt better 6
Did not help 332
Adverse events 81
Too costly 14
Other 59
[1]
Measure Description: Physicians reported the single, main reason for a participant to discontinue a medication during the Baseline visit. The number of participants included those who discontinued medication before starting fibromyalgia treatment at Baseline.
1.Primary Outcome
Title Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Hide Description [Not Specified]
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who took part in all follow-up interviews.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1073
Mean (Standard Deviation)
Unit of Measure: medications
5.2  (2.1)
2.Primary Outcome
Title Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication
Hide Description Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had non-missing covariates used in logistic regression.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
Age over 65
0.535
(0.338 to 0.845)
Female physician
1.665
(1.192 to 2.325)
Rheumatology versus Primary Care Physician (PCP)
2.662
(1.864 to 3.802)
Other specialty versus PCP
2.671
(1.758 to 4.060)
Use of opioids
0.667
(0.498 to 0.893)
Use of NSAIDs
0.447
(0.337 to 0.594)
Number of baseline medications taken
1.394
(1.247 to 1.558)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments P-value for age over 65.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments P-value for female physicians.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Rheumatology versus PCP.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for other specialty versus PCP.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments P-value for use of opioids.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for use of NSAIDs.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for number of medications participants were taking.
Method Regression, Logistic
Comments [Not Specified]
3.Primary Outcome
Title Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
Hide Description Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had non-missing covariates used in logistic regression.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 212
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
GAD-7
1.06
(1.01 to 1.12)
Pregabalin use
2.69
(1.16 to 6.22)
NSAID use
2.25
(1.00 to 5.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments P-value for GAD-7 score.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments P-value for pregabalin use.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fibromyalgia (FM) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-value for NSAID use.
Method Regression, Logistic
Comments [Not Specified]
4.Secondary Outcome
Title Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Hide Description Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 978
Measure Type: Number
Unit of Measure: participants
Felt better 49
Did not help 637
Adverse events 731
Too costly 121
Other 458
No reason provided 116
5.Secondary Outcome
Title Percentage of Participants Who Discontinued Opioids
Hide Description [Not Specified]
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who were using opioids at Baseline.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 412
Measure Type: Number
Unit of Measure: percentage of participants
Discontinued opioid use by 3 months of treatment 11.9
Discontinued opioid use by 6 months of treatment 15.3
Discontinued opioid use by 12 months of treatment 22.0
6.Secondary Outcome
Title Hazard Ratios for Factors Associated With Discontinued Opioid Use
Hide Description Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who were using opioids at Baseline.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 325
Measure Type: Number
Unit of Measure: hazard ratio
Age: younger more likely to discontinue 0.97
BPI-I: higher baseline score=more likely 1.57
PHQ-15: lower baseline score=more likely 0.93
7.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Hide Description Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1202
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.66  (2.12)
8.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
Hide Description BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1172
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.33  (1.72)
9.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
Hide Description FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1182
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.81  (13.47)
10.Secondary Outcome
Title Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
Hide Description The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1180
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.28  (7.26)
11.Secondary Outcome
Title Number of Outpatient Visits Due to Fibromyalgia (FM)
Hide Description [Not Specified]
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1600
Mean (Standard Deviation)
Unit of Measure: outpatient visits
21.2  (28.6)
12.Secondary Outcome
Title Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Hide Description [Not Specified]
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1598
Mean (Standard Deviation)
Unit of Measure: ER visits
0.9  (2.5)
13.Secondary Outcome
Title Number of Days of Partial Care for Fibromyalgia (FM) Participants
Hide Description Partial (day or night) care included day care, day nursing home, and partial hospitalization.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1600
Mean (Standard Deviation)
Unit of Measure: days
Partial day care 1.2  (8.1)
Partial night care 0.6  (3.9)
14.Secondary Outcome
Title Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Hide Description Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1600
Mean (Standard Deviation)
Unit of Measure: days
Days family missed paid work 2.7  (12.2)
Days family used paid caregiver 2.7  (17.6)
15.Secondary Outcome
Title Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Hide Description Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1599
Mean (Standard Deviation)
Unit of Measure: days
36.4  (76.6)
16.Secondary Outcome
Title Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Hide Description Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1600
Mean (Standard Deviation)
Unit of Measure: days
Days participant stayed in bed due to FM 40.6  (58.2)
Days participant reduced activity by at least half 86.5  (76.3)
Days participant received disability income 98.2  (148.3)
17.Secondary Outcome
Title Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Hide Description Participant productivity was described as the number of days a participant missed work due to FM.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included enrolled participants who had at least 1 follow-up visit.
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description:
FM participants starting any new pharmacologic FM agent.
Overall Number of Participants Analyzed 1590
Mean (Standard Deviation)
Unit of Measure: days
25.0  (56.1)
Time Frame [Not Specified]
Adverse Event Reporting Description This observational study was not designed to collect or monitor safety data. To maintain non-interventional methods, per the protocol/study design, adverse events (AEs) were not collected, and physicians were instructed to handle AEs according to laws and regulations for US-marketed drugs.
 
Arm/Group Title Fibromyalgia (FM) Participants
Hide Arm/Group Description FM participants starting any new pharmacologic FM agent.
All-Cause Mortality
Fibromyalgia (FM) Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fibromyalgia (FM) Participants
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fibromyalgia (FM) Participants
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00725101     History of Changes
Other Study ID Numbers: 11540
F1J-MC-B020 ( Other Identifier: Eli Lilly and Company )
First Submitted: July 28, 2008
First Posted: July 30, 2008
Results First Submitted: April 27, 2012
Results First Posted: June 1, 2012
Last Update Posted: November 30, 2012